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First Asian Regulatory Approvals Received for VivaGel® BV

Aug 15th, 2019

Melbourne, Australia: Starpharma today announced that it has received the first regulatory approvals in South East Asia for VivaGel® BV. Mundipharma will be rolling-out the product in Asia under the brand name BETADINETM BV Gel.

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Starpharma commences phase 1/2 DEP® irinotecan trial

Aug 8th, 2019

Starpharma today announced that it has received the necessary regulatory and ethics approvals and will  commence its phase 1/2 clinical trial for DEP® irinotecan. The objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP® irinotecan to define a recommended phase 2 dose (RP2D), and to determine anti-tumour efficacy of the product in select tumour types. DEP® irinotecan is the third DEP® product to enter the clinic from Starpharma’s internal portfolio with a fourth, partnered DEP® candidate, AZD0466, also set to enter the clinic later this year.

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Quarterly Cashflow Report

Jul 16th, 2019

Melbourne, Australia: Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 June 2019.

 

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Shareholder Update July 2019

Jul 1st, 2019

In this issue: 

>> VivaGel® BV launched in Europe & Australia; US regulatory progress

>> VivaGel condom launched in Japan by Okamoto

>> DEP® docetaxel & DEP® cabazitaxel clinical trial update; DEP® irinotecan trial start & new data

>> Starpharma signs second commercial oncology agreement with AstraZeneca

>> AstraZeneca highlights AZD0466 at 2019 ASCO meeting & upcoming US FDA IND 

>> Patent published for AstraZeneca Bcl2/xL DEP conjugates

>> DEP® radiotherapeutics

>> Outlook, recent news & events

 

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VivaGel® BV launched in Europe

Jun 27th, 2019

Starpharma today announced that VivaGel® BV has been launched in Europe under the brand name Betadine BVTM. The product has been launched in several countries in Europe, including Germany, with further roll-out in additional European countries during the year.

 

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Starpharma presents at Macquarie Emerging Leaders Forum

Jun 20th, 2019

Starpharma has been invited to present at the Macquarie Emerging Leaders Corporate Forum in Melbourne. The Macquarie Emerging Leaders Corporate Forum provides Starpharma with an opportunity to present to more than 100 investors from Melbourne and Sydney.

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US patent granted for DEP Bcl2/xL inhibitor conjugates

Jun 12th, 2019

Starpharma announced the first patent for DEP® Bcl2/xL inhibitor conjugates, developed in collaboration with AstraZeneca, has been granted by the US Patent and Trademark Office. These patented DEP® Bcl2/xL inhibitor conjugates combine Starpharma’s innovative DEP® delivery technology with AstraZeneca’s novel Bcl2/xL inhibitors, which are being investigated for treating various cancers, including leukemias.

 

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Okamoto launches VivaGel® condom in Japan

Jun 4th, 2019

Starpharma today announced that the VivaGel® condom has been launched in Japan under Okamoto’s leading and highly successful Zero Zero Three (003) brand. This is the first condom with antiviral coating in Japan and will also carry Starpharma’s VivaGel® brand.

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Starpharma signs second oncology agreement with AstraZeneca

Jun 3rd, 2019

Starpharma today announced a Development and Option Agreement with AstraZeneca (LON: AZN) to progress the development of a Dendrimer Enhanced Product (DEP®) version of an undisclosed AstraZeneca major marketed oncology medicine. This is the second DEP® commercial agreement Starpharma has signed with AstraZeneca, the first agreement being a multiproduct licence which covers novel oncology drug candidates such as AZD0466 (a Bcl2/xL inhibitor).

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Starpharma presents at UBS Healthcare Conference

May 29th, 2019

Starpharma has been invited to present today at the UBS Australian Emerging Companies Conference - Healthcare and Biotech – in Sydney. The UBS Healthcare Conference provides Starpharma with an opportunity to present to approximately 100 institutional investors.

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DEP® irinotecan combination outperforms in refractory human colon cancer model

May 24th, 2019

Starpharma today announced that its patented nanoparticle formulation, DEP® irinotecan, showed significant efficacy and safety benefits over leading colorectal cancer drugs irinotecan (Camptosar®) and cetuximab (Erbitux®), in the irinotecan-refractory HT-29 human colon cancer model.

These impressive results were despite the fact that these standard colorectal cancer (CRC) treatments, Camptosar® and/or Erbitux®, showed limited activity in this preclinical model.

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Regulatory progress for VivaGel BV in the US

May 23rd, 2019

Starpharma has received formal feedback from the recent meeting held with the US FDA in relation to the approval for two related bacterial vaginosis (BV) indications - BV treatment and the prevention of recurrent BV in the United States.

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Starpharma to present at US Drug Delivery Conference

May 7th, 2019

Starpharma today announced that it will be presenting its DEP® platform at the 2nd Annual Drug Delivery West conference in San Francisco on 6-7 May 2019 (US time).

 

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Starpharma presents at Macquarie Australia Conference

May 1st, 2019

Melbourne, Australia; 1 May 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) has been invited to present today at the Macquarie Australia Conference in Sydney. The Macquarie Australia Conference is a leading investment event in Australia and attracts more than 800 investors from around the world, including Asia, Europe and North America.

 

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Quarterly Cashflow Report

Apr 29th, 2019

Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2019.

 

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First VivaGel BV launch globally in Australia by Aspen

Apr 16th, 2019

Starpharma today announced that VivaGel® BV has been officially launched in Australia by Aspen Pharmacare (Aspen) as Fleurstat BVgel. The product has undergone distribution across Australia and is already available in some pharmacies. It will be progressively rolled-out nationally over the coming weeks. This is the first launch of VivaGel® BV in the world and further launches by Mundipharma are expected in Europe in May/June this year.

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Starpharma meets with US FDA to discuss VivaGel® BV

Apr 11th, 2019

 

Starpharma today announced that a meeting was held with the US FDA overnight as part of the process to clarify and address FDA’s request for confirmatory data prior to the approval of VivaGel® BV in the US. This meeting was attended by senior representatives of Starpharma as well as internationally recognised Key Opinion Leaders in BV, statisticians and the Company’s expert FDA regulatory consultants, which include former senior FDA clinical personnel. 

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Starpharma Investor Presentation to Goldman Sachs Conference

Apr 3rd, 2019

Starpharma will today present to institutional investors at the Goldman Sachs Tenth Annual Emerging Companies Conference in Sydney.

 

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Shareholder Update March 2019

Mar 18th, 2019

In this issue: 

>> Fleurstat BVgel - Australian launch

>> Mundipharma's European launch of VivaGel® BV

>> Mundipharma's international roll-out of VivaGel® BV

>> FDA meeting to discuss VivaGel® BV approval in the US

 Download: Shareholder Update March 2019 (pdf file, 453kb)

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Starpharma receives $4.0M R&D tax incentive refund

Mar 12th, 2019

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that it has received a $4.0M R&D tax incentive refund which relates to the costs of research and development during the 2018 Financial Year. The refund is in respect of eligible R&D activities across Starpharma’s portfolio, including VivaGel® and DEP® programs. This amount was not included in Starpharma’s cash balance reported in the Company’s Interim Report for the half-year ended 31 December 2018.

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Starpharma Interim Report and Half-Year Financial Results

Feb 27th, 2019

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its interim report and financial results for the half-year ended 31 December 2018.

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Quarterly Cashflow Report

Jan 30th, 2019

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2018

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Shareholder Update January 2019

Jan 17th, 2019

In this issue: 

>> FDA requests further data for VivaGel® BV approval in the US

>> Launch of VivaGel® BV in multiple territories

>> VivaGel® BV licensed to ITF Pharma in the US

>> VivaGel® condom approved in Japan

>> Clinical trials for internal DEP® products progressing well

>> Patent published for AstraZeneca-DEP® drugs: DEP® Bcl2/xL inhibitors show compelling efficacy & synergy in combination

>> DEP® docetaxel & DEP® cabazitaxel outperformed both gemcitabine & Abraxane®

>> SPL7013 eye drops for viral conjunctivitis

>> Partnering activities 

>> Macquarie initiates coverage of Starpharma

>> Outlook

 Download: Shareholder Update January 2019 (pdf file, 557kb)

 

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VivaGel® condom receives final regulatory approval in Japan

Jan 2nd, 2019

Melbourne, Australia; 2 January 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the VivaGel® condom has received final regulatory approval and is now able to be marketed in Japan, following the completion of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) review of the product’s medical device classification and associated data. This final approval follows on from the previously granted regulatory certification, which was attained for the VivaGel® condom.

 

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US FDA requests further data for VivaGel® BV approval

Dec 27th, 2018

Melbourne, Australia: Starpharma today received advice from the US FDA that it will require confirmatory clinical data prior to approving VivaGel® BV for treatment of bacterial vaginosis (BV) and the prevention of recurrent BV (rBV).

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US VivaGel® BV licensed for A$142M milestones, plus royalties

Dec 20th, 2018

Melbourne, Australia: Starpharma and ITF Pharma today announced they have signed a licence for the sales and marketing rights to VivaGel® BV in the United States. Starpharma will be eligible to receive up to US$101M (A$142M) in regulatory approval and commercialisation milestones in addition to attractive tiered royalties on sales.

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US patent granted for SPL7013 eye drops for conjunctivitis

Dec 12th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the US Patent and Trademark Office has granted a patent for SPL7013 ophthalmic drops for viral conjunctivitis. The patent has been granted with broad claims for treating and preventing microbial infections of the eye, including adenoviral conjunctivitis, bacterial conjunctivitis and other eye infections. The patent term is to 2033.

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AGM - Chairman address and CEO presentation

Nov 29th, 2018

Melbourne, Australia: Attached is the Chairman’s address together with the CEO’s presentation to the Annual General Meeting of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), to be held at 3.00pm today.

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DEP® docetaxel and DEP® cabazitaxel outperform in human pancreatic cancer model

Nov 16th, 2018

Melbourne, Australia: Starpharma today announced that its proprietary DEP® docetaxel and DEP® cabazitaxel products, which are both currently in the clinic, showed significant efficacy and safety benefits over gemcitabine (Gemzar®) alone, Abraxane® (Nab-paclitaxel) alone and in combination, in a human pancreatic cancer model. These impressive efficacy results were despite the fact that these standard pancreatic cancer treatments, gemcitabine and/or Abraxane® showed limited activity in this model.

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Quarterly Cashflow Report

Oct 26th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2018

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Starpharma Investor Presentation for Citi Conference

Oct 17th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) will today participate in Citi's 10th Annual Australian and New Zealand Investment Conference in Sydney.

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DEP® irinotecan outperforms in pancreatic cancer model

Sep 5th, 2018

Melbourne, Australia: Starpharma today announced that its proprietary DEP® irinotecan development candidate showed significant efficacy and safety benefits over standard irinotecan in combination with 5-FU in a mouse xenograft model of human pancreatic cancer (Figure 1 and 2). The human pancreatic tumour model used in this study virtually did not respond to the traditional irinotecan regimen (irinotecan + 5-FU), whereas complete tumour regression and 100% survival was achieved using Starpharma’s DEP® irinotecan.

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AstraZeneca’s DEP Bcl2/xL inhibitors show compelling efficacy and synergy in combination

Aug 31st, 2018

Melbourne, Australia; Starpharma today announced AstraZeneca’s first patent application on DEP® Bcl2/xL conjugates has been published by the World Intellectual Property Organisation. These DEP® Bcl2/xL conjugates combine Starpharma’s innovative DEP® delivery technology with AstraZeneca’s novel Bcl2/xL inhibitor for treating various cancers, including leukemias.

The published patent application shows compelling efficacy data on DEP® Bcl2/xL conjugates, both alone and in combination with other leading current anti-cancer treatments, in various preclinical human tumour models.

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Annual report and full year financial results

Aug 21st, 2018

Melbourne, Australia: Starpharma today released its annual report and financial results for the year ended 30 June 2018.

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Quarterly Cashflow Report

Jul 17th, 2018

Melbourne, Australia; Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 June 2018.

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VivaGel® BV NDA advances to next stage of FDA review

Jul 9th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the US FDA has completed its filing review of the VivaGel® BV New Drug Application (NDA), with no issues identified, and confirmed its progress to the next stage.

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Starpharma licenses VivaGel® BV to Mundipharma for Europe

Jun 27th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) and Mundipharma today announced they have signed a licence agreement for the sales and marketing rights to VivaGel®BV for 43 countries in Europe, Russia, the Commonwealth of Independent States (CIS) and the balance of countries in Latin America. This deal builds on the VivaGel® BV licence signed with Mundipharma in May 2018 for Asia, the Middle East, Africa and parts of Latin America. 

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Mundipharma licenses Starpharma’s VivaGel® BV

May 3rd, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) and Mundipharma today announced they have signed a multi-region licence for the sales and marketing rights to VivaGel® BV in Asia (including China, Japan and Korea), the Middle East, Africa and the majority of Latin America.

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Quarterly Cashflow Report

Apr 30th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2018.

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Starpharma completes US New Drug Application for VivaGel® BV

Apr 30th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that its rolling new drug application (NDA) for VivaGel® BV including two indications, for the treatment of bacterial vaginosis (BV) and prevention of BV, has been completed, and the final module of the NDA will be submitted to the US Food and Drug Administration (FDA) on Monday 30 April 2018 (US time).

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Starpharma to present at OTCQX Virtual Investor Conference

Apr 11th, 2018

Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that as part of its OTCQX investor communications, a pre-recorded presentation by Chief Executive Officer Dr Jackie Fairley will be broadcast at VirtualInvestorConferences.com on Thursday 12 April 2018 at 10:30am (US ET time).

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Starpharma on CommSec’s The Executive Series

Mar 14th, 2018

Starpharma CEO Dr Jackie Fairley speaks with CommSec’s Tom Piotrowski about the Company’s performance since March 2017, its partnership with AstraZeneca and upcoming milestones.

To view the video, click here

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Starpharma CEO Dr Jackie Fairley on Channel 9’s The Today Show for International Women’s Day

Mar 8th, 2018

As part of International Women’s Day, Starpharma CEO Dr Jackie Fairley appeared with the Federal Minister for Women Kelly O’Dwyer and Today Show presenter Georgie Gardiner to discuss women in the workforce and gender equality.

To view the video, click here.

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Starpharma Interim Report and Half-Year Financial Results

Feb 26th, 2018

Starpharma today released its interim report and financial results for the half-year ended 31 December 2017.

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Starpharma receives $3.7M R&D tax incentive refund

Feb 22nd, 2018

Starpharma today announced that it has received a $3.7M R&D tax incentive refund associated with FY17 expenditures. The refund relates to eligible R&D expenditure across Starpharma’s portfolio, including VivaGel® and DEP® programs.

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Shareholder Update February 2018

Feb 19th, 2018

In this issue: 

>> New sites open for the DEP® docetaxel phase 2 trial

>> DEP® cabazitaxel phase 1 / 2 trial commences

>> VivaGel® BV NDA submission lodged under Fast Track program

>> VivaGel® BV approved by TGA

>> DEP® irinotecan progressing towards the clinic

>> AstraZeneca-Starpharma collaboration

>> Extensive global licensing negotiations for VivaGel® BV

>> Positive market research findings for VivaGel® BV 

>> Q2 Cashflow Report at 31 December 2017

>> OTCQX market recognition

>> Starpharma News & Events

>> Outlook

 Download: Shareholder Update February 2018 (pdf file, 1.5mb)

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Starpharma to commence DEP® cabazitaxel phase 1/2 trial

Jan 31st, 2018

Starpharma today announced that it has received regulatory and ethics approvals to commence its phase 1/2 clinical trial for DEP® cabazitaxel. The objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP® cabazitaxel, to define a recommended phase 2 dose (RP2D), and then to determine anti-tumour efficacy of the product in select tumour types.

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VivaGel® BV treatment clinical submission under rolling submission

Dec 21st, 2017

Melbourne, Australia; 21 December 2017: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that it has completed the VivaGel® BV treatment clinical section of the NDA clinical module, which will be submitted to the FDA under Starpharma’s rolling submission on Friday 22 December 2017 (US time). 

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NDA submission for Starpharma’s VivaGel® BV

Nov 21st, 2017

BioSpectrum Asia reported on Starpharma’s NDA submission for VivaGel® BV, noting that Starpharma is one of the few Australian companies to take a locally developed product to this stage.

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Starpharma receives TGA marketing approval for VivaGel® BV

Oct 25th, 2017

Online financial news portal Finance News Network reported Starpharma received TGA marketing approval for VivaGel® BV, which is expected to be available in pharmacies in the new year under the Fleurstat™ brand.

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